Fractional Flow Reserve versus Angiography for Guiding Percutaneous Coronary Intervention (FAME)

The FAME (Fractional Flow Reserve vs. Angiography for Multivessel Evaluation) trial randomized 1,005 patients with multivessel coronary artery disease undergoing PCI to FFR-guided revascularization versus angiography-guided revascularization. In FFR-guided PCI, stenting was deferred for lesions with FFR >0.80; in angiography-guided PCI, all visually significant stenoses (≥50%) were stented.

FFR-guided PCI significantly reduced the primary composite outcome of death, nonfatal MI, and repeat revascularization at 1 year (13.2% vs 18.3%; p=0.02) compared with angiography-guided PCI. FFR guidance reduced mean number of stents placed per patient (1.9 vs 2.7), procedure time, and contrast use — with better outcomes despite treating fewer stenoses. At 2-year follow-up, the mortality and MI benefit persisted.

FAME established that angiographic appearance alone is an unreliable guide to which stenoses actually limit blood flow — the physiological parameter that determines myocardial ischemia and determines which stenoses benefit from revascularization. A 70% stenosis by angiography may or may not be hemodynamically significant; FFR ≤0.80 identifies which stenoses are functionally flow-limiting and which are not.

The trial’s practical lesson for the broader CAD management framework: anatomical imaging (angiography, CCTA) identifies coronary stenoses but cannot reliably predict which will cause ischemia. Physiological assessment — either invasive FFR or noninvasive CT-FFR — is necessary to guide intervention decisions appropriately. FFR-guided PCI is now a Class I recommendation in revascularization guidelines.

We rate the evidence strong. The FAME trial establishing that FFR-guided PCI reduces death, MI, and repeat revascularization compared with angiography-guided PCI — a landmark study demonstrating that physiological assessment outperforms anatomical assessment for revascularization guidance.